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FDA 510(k)

COMPLEMENT C4 NEPHELOMETRIC ASSAY

K-Number: K801361 · 1980-06-30

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-06-30
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT C4 NEPHELOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801361. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLEMENT C4 NEPHELOMETRIC ASSAY?

COMPLEMENT C4 NEPHELOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801361.

When did COMPLEMENT C4 NEPHELOMETRIC ASSAY receive FDA 510(k) clearance?

COMPLEMENT C4 NEPHELOMETRIC ASSAY received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801361.

Who is the listed applicant for COMPLEMENT C4 NEPHELOMETRIC ASSAY?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPLEMENT C4 NEPHELOMETRIC ASSAY?

The FDA product code for COMPLEMENT C4 NEPHELOMETRIC ASSAY is DBI.

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Other records listing J.T. Baker Chemical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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Related Devices (Code: DBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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